COVIDIEN Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled
COVIDIEN Medtronic is recalling Endo GIA universal stapler kits because a missing sled component may prevent proper staple deployment, risking bleeding or leakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is FDA Class II, but the hazard involves a device failure that can lead to bleeding or leakage of luminal contents, which constitutes significant injury reports or risk thereof. While not explicitly stated as 'Class I' or 'death', the potential for serious physiological harm (bleeding/leakage) in a surgical context aligns with Severe criteria regarding significant injury risk.
Plain-English summary
COVIDIEN Medtronic is voluntarily recalling 171,271 units of the BOX KIT00713 KIT BY PASS. This kit contains Endo GIA universal and Endo GIA universal XL staplers used to divide tissue by placing two triple-staggered rows of titanium staples.
The recall was initiated because the device may be missing a sled component. The sled is responsible for deploying the staples. Without this component, the stapler may fail to form a proper staple line when tissue is divided.
This failure can lead to serious complications for patients, including bleeding or leakage of luminal contents. The affected products are distributed worldwide and within the US Nationwide. Affected lots include 0214364763, 0214456590, 0214435328, 0214983139, 0215042012, 0215234651, and 0215288296.
Healthcare providers should inspect their inventory for these specific lot numbers and stop using the affected devices immediately. Patients who have received these devices should consult their healthcare provider.
The recalled product
- Product
- BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 171,271
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lots 0214364763
- 0214456590
- 0214435328
- 0214983139
- 0215042012
- 0215234651
- 0215288296
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by COVIDIEN MEDTRONIC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 40 products in this recall →Related recalls
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